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12 results on '"Simonelli, P"'

1. Actigraphic sleep patterns and cognitive decline in the Hispanic Community Health Study/Study of Latinos

Author

Agudelo, Christian, Tarraf, Wassim, Wu, Benson, Wallace, Douglas M, Patel, Sanjay R, Redline, Susan, Kaur, Sonya, Daviglus, Martha, Zee, Phyllis C, Simonelli, Guido, Mossavar‐Rahmani, Yasmin, Sotres‐Alvarez, Daniela, Zeng, Donglin, Gallo, Linda C, González, Hector M, and Ramos, Alberto R

Subjects
Biological Psychology, Psychology, Sleep Research, Neurosciences, Basic Behavioral and Social Science, Lung, Brain Disorders, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Clinical Research, Alzheimer's Disease, Aging, Mental Health, Behavioral and Social Science, Acquired Cognitive Impairment, Dementia, Neurodegenerative, Good Health and Well Being, Actigraphy, Cognitive Dysfunction, Female, Hispanic or Latino, Humans, Male, Middle Aged, Neuropsychological Tests, Prospective Studies, Public Health, Risk Factors, Sleep, Surveys and Questionnaires, United States, actigraphy, cognitive decline, cohort studies, Hispanic, Latinos, risk factors in epidemiology, sleep, Hispanic/Latinos, Clinical Sciences, Geriatrics, Clinical sciences, Biological psychology
Abstract

IntroductionWe determined if actigraphy-derived sleep patterns led to 7-year cognitive decline in middle-aged to older Hispanic/Latino adults.MethodsWe examined 1035 adults, 45 to 64 years of age, from the Hispanic Community Health Study/Study of Latinos. Participants had repeated measures of cognitive function 7 years apart, home sleep apnea studies, and 1 week of actigraphy. Survey linear regression evaluated prospective associations between sleep and cognitive change, adjusting for main covariates.ResultsLonger sleep-onset latency was associated with declines in global cognitive function, verbal learning, and verbal memory. Longer sleep-onset latency was also cross-sectionally associated with verbal learning, verbal memory, and word fluency. Sleep fragmentation was not associated with cognitive change.ConclusionIn a cohort of mostly middle-aged Hispanic/Latinos, actigraphy-derived sleep-onset latency predicted 7-year cognitive change. These findings may serve as targets for sleep interventions of cognitive decline.

Published
2021

2. The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned

Author

Yusen, Roger D, Criner, Gerard J, Sternberg, Alice L, Au, David H, Fuhlbrigge, Anne L, Albert, Richard K, Casaburi, Richard, Stoller, James K, Harrington, Kathleen F, Cooper, J Allen D, Diaz, Philip, Gay, Steven, Kanner, Richard, MacIntyre, Neil, Martinez, Fernando J, Piantadosi, Steven, Sciurba, Frank, Shade, David, Stibolt, Thomas, Tonascia, James, Wise, Robert, Bailey, William C, Sampong, Ernestina, Sloan, Karin, Wagner, Ashley, Anderson, Susan, Moy, Marilyn, Okunbor, Osarenoma, Marlow, Scott, Meli, Yvonne, Rice, Richard, Aboussouan, Loutfi S, Castele, Robert, Parambil, Joseph, Khatri, Sumita, Pande, Aman, Zein, Joe, Olbrych, Thomas, Alkins, Stephan, Jocko, Christine, Rahaghi, Franck, Barton, Jean, Underwood, Jennifer, Make, Barry, Davies, John, Mularski, Richard, Naleway, Allison, Vertrees, Sarah, Porszasz, Janos, Walker, Peggy, Indelicato, Renee, Specht, Lennard, Ellstrom, Kathleen, Portillo, Jamie, Horak, David, Tiep, Brian, Barnett, Mary, Drake, Janice, Rittinger, Mahasti, Compton, Rachael, Miller, Scott, Panos, Ralph J, Lach, Laura A, Criner, Gerard, Grabianowski, Carla, Cordova, Francis, Desai, Parag, Krachman, Samuel, Mamary, James, Marchetti, Nathaniel, Satti, Aditi, Mumm, Eileen, Vega-Olivo, Michelle, Hua, Jenny, Tauch, Vanna, Criner, Lii-Yoong, Jacobs, Michael, Rising, Peter, Simonelli, Paul, Mitchell, Michele, Lammi, Matthew, Romaine, Connie, Lee, Howard, Ianacone, Mary, Scharf, Steven, Bell-Farrell, Wanda, Mador, M Jeffery, Rahman, Ayesha, Zaman, Mumtaz, Hill, Lisa, and Platt, Alec

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Female, Geography, Humans, Long-Term Care, Male, Middle Aged, Multicenter Studies as Topic, Oxygen, Oxygen Inhalation Therapy, Patient Admission, Pulmonary Disease, Chronic Obstructive, Quality of Life, Randomized Controlled Trials as Topic, Time Factors, United States, chronic obstructive pulmonary disease, hypoxemia, oxygen, randomized controlled trial, survival, LOTT Research Group *, LOTT Research Group, Cardiovascular medicine and haematology, Clinical sciences
Abstract

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Published
2018

3. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal

Author

Ott, PA, Piha-Paul, SA, Munster, P, Pishvaian, MJ, van Brummelen, EMJ, Cohen, RB, Gomez-Roca, C, Ejadi, S, Stein, M, Chan, E, Simonelli, M, Morosky, A, Saraf, S, Emancipator, K, Koshiji, M, and Bennouna, J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Trials and Supportive Activities, Clinical Research, Patient Safety, Cancer, Digestive Diseases, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Aged, Aged, 80 and over, Anal Canal, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Anus Neoplasms, Carcinoma, Squamous Cell, Disease-Free Survival, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Treatment Outcome, squamous cell advanced anal carcinoma, pembrolizumab, immunotherapy, PD-1, PD-L1, KEYNOTE-028, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Published
2017

4. Identification and population history of CYP4V2 mutations in patients with Bietti crystalline corneoretinal dystrophy

Author

Jiao, Xiaodong, Li, Anren, Jin, Zi-Bing, Wang, Xinjing, Iannaccone, Alessandro, Traboulsi, Elias I, Gorin, Michael B, Simonelli, Francesca, and Hejtmancik, J Fielding

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Genetics, Clinical Research, Human Genome, Rare Diseases, Aetiology, 2.1 Biological and endogenous factors, Arabs, Asian, Corneal Dystrophies, Hereditary, Cytochrome P450 Family 4, Exons, Humans, Mutation, Pedigree, Retinal Diseases, Clinical Sciences, Genetics & Heredity, Clinical sciences
Abstract

To identify known and novel CYP4V2 mutations in patients with Bietti crystalline cornea (BCD), expand the spectrum of CYP4V2 mutations, and characterize the population history of the c.802-8_810del17insGC mutation common in Asian populations, genomic DNA was isolated from peripheral blood samples from 58 unrelated patients with clinical diagnoses of BCD. Exons and flanking intronic regions of the CYP4V2 gene were dideoxy DNA sequenced. Nonpathogenic polymorphisms were excluded and known mutations were identified by sequencing 192 unaffected individuals from similar ethnic backgrounds and examination of online databases. The age of the c.802-8_810del17insGC mutation was estimated using three independent approaches. A total of 28 CYP4V2 mutations, 9 of which were novel, were detected in the 58 patients with BCD. These included 19 missense, 4 nonsense, 2 deletion, 2 splice site, and 1 insertion-deletion mutations. Two missense variants of uncertain significance were also detected. The age of the c.802-8_810del17insGC mutation was estimated to be 1040-8200 generations in the Chinese and 300-1100 generations in the Japanese populations. These results expand the mutation spectrum of CYP4V2, and provide insight into the origin of the c.802-8_810del17insGC mutation in the Chinese population and its transmission to the Japanese population.

Published
2017

5. The Neighborhood Social Environment and Objective Measures of Sleep in the Multi-Ethnic Study of Atherosclerosis

Author

Johnson, Dayna A, Simonelli, Guido, Moore, Kari, Billings, Martha, Mujahid, Mahasin S, Rueschman, Michael, Kawachi, Ichiro, Redline, Susan, Roux, Ana V Diez, and Patel, Sanjay R

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Psychology, Basic Behavioral and Social Science, Behavioral and Social Science, Health Disparities, Prevention, Sleep Research, Minority Health, 2.3 Psychological, social and economic factors, Actigraphy, Aged, Aged, 80 and over, Atherosclerosis, Bayes Theorem, Cross-Sectional Studies, Ethnicity, Female, Humans, Male, Middle Aged, Racial Groups, Residence Characteristics, Risk Factors, Safety, Sleep, Sleep Deprivation, Social Environment, Surveys and Questionnaires, Time Factors, United States, Neighborhoods, sleep duration, sleep timing, actigraphy, Neighborhoods, sleep duration, sleep timing, actigraphy, Medical and Health Sciences, Psychology and Cognitive Sciences, Neurology & Neurosurgery, Biological sciences, Biomedical and clinical sciences
Abstract

To investigate cross-sectional associations of neighborhood social environment (social cohesion, safety) with objective measures of sleep duration, timing and disturbances.A racially/ethnically diverse population of men and women (N=1949) aged 54-93 participating in the Multi-Ethnic Study of Atherosclerosis Sleep and Neighborhood Ancillary studies. Participants underwent 1-week actigraphy between 2010 and 2013. Measures of sleep duration, timing and disruption were averaged over all days. Neighborhood characteristics were assessed via questionnaires administered to participants and an independent sample within the same neighborhood and aggregated at the neighborhood (census tract, N=783) level using empirical Bayes estimation. Multilevel linear regression models were used to assess the association between the neighborhood social environment and each sleep outcome.Neighborhood social environment characterized by higher levels of social cohesion and safety were associated with longer sleep duration and earlier sleep midpoint. Each 1 standard deviation higher neighborhood social environment score was associated with 6.1 minutes longer (95% Confidence Interval (CI): 2.0, 10.2) sleep duration and 6.4 minutes earlier (CI: 2.2, 10.6) sleep midpoint after adjustment for age, sex, race, socioeconomic status and marital status. These associations persisted after adjustment for other risk factors. Neighborhood social factors were not associated with sleep efficiency or sleep fragmentation index.A more favorable neighborhood social environment is associated with longer objectively measured sleep duration and earlier sleep timing. Intervening on the neighborhood environment may improve sleep and subsequent health outcomes.

Published
2017

6. Analysis of the ABCA4 genomic locus in Stargardt disease

Author

Zernant, Jana, Xie, Yajing, Ayuso, Carmen, Riveiro-Alvarez, Rosa, Lopez-Martinez, Miguel-Angel, Simonelli, Francesca, Testa, Francesco, Gorin, Michael B, Strom, Samuel P, Bertelsen, Mette, Rosenberg, Thomas, Boone, Philip M, Yuan, Bo, Ayyagari, Radha, Nagy, Peter L, Tsang, Stephen H, Gouras, Peter, Collison, Frederick T, Lupski, James R, Fishman, Gerald A, and Allikmets, Rando

Subjects
Biological Sciences, Bioinformatics and Computational Biology, Genetics, Clinical Research, Biotechnology, Human Genome, Aetiology, 2.1 Biological and endogenous factors, ATP-Binding Cassette Transporters, Alleles, Black People, Case-Control Studies, Comparative Genomic Hybridization, Exons, Female, Gene Expression, Genes, Recessive, Genetic Loci, Genetic Variation, Heterozygote, High-Throughput Nucleotide Sequencing, Homozygote, Humans, Introns, Macular Degeneration, Male, Mutation, Pedigree, Stargardt Disease, White People, Medical and Health Sciences, Genetics & Heredity
Abstract

Autosomal recessive Stargardt disease (STGD1, MIM 248200) is caused by mutations in the ABCA4 gene. Complete sequencing of ABCA4 in STGD patients identifies compound heterozygous or homozygous disease-associated alleles in 65-70% of patients and only one mutation in 15-20% of patients. This study was designed to find the missing disease-causing ABCA4 variation by a combination of next-generation sequencing (NGS), array-Comparative Genome Hybridization (aCGH) screening, familial segregation and in silico analyses. The entire 140 kb ABCA4 genomic locus was sequenced in 114 STGD patients with one known ABCA4 exonic mutation revealing, on average, 200 intronic variants per sample. Filtering of these data resulted in 141 candidates for new mutations. Two variants were detected in four samples, two in three samples, and 20 variants in two samples, the remaining 117 new variants were detected only once. Multimodal analysis suggested 12 new likely pathogenic intronic ABCA4 variants, some of which were specific to (isolated) ethnic groups. No copy number variation (large deletions and insertions) was detected in any patient suggesting that it is a very rare event in the ABCA4 locus. Many variants were excluded since they were not conserved in non-human primates, were frequent in African populations and, therefore, represented ancestral, and not disease-associated, variants. The sequence variability in the ABCA4 locus is extensive and the non-coding sequences do not harbor frequent mutations in STGD patients of European-American descent. Defining disease-associated alleles in the ABCA4 locus requires exceptionally well characterized large cohorts and extensive analyses by a combination of various approaches.

Published
2014

7. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Author

Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, Ap, Rivellese, Aa, Squatrito, S, Giorda, Cb, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, Ac, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, Ac, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, IT) study group, Thiazolidinediones Or Sulfonylureas Cardiovascular Accidents Intervention Trial (TOSCA., Collaborators: Vaccaro O, Italian Diabetes Society., D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Corsi, A, Dodesini, Ar, Reggiani, Gm, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi MS, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, Mr, Franzetti, I, Radin, R, Annunziata, F, Bonabello, La, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, Mpa, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta GG, De Gregorio, A, D'Andrea, S, Giuliani, Ae, Polidoro, Wl, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, Ml, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, Mc, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, Pm, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, Gv, Loi, C, Oldani, M, Bottalico, Ml, Pellegata, B, Bonomo, M, Menicatti, Lsm, Resi, V, Bertuzzi, F, Disoteo, Eo, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, Sm, Turco, Aa, Costagliola, L, Corte, Gd, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, Nc, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Babini, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, Ks, Penno, G, Livraga, S, Calzoni, F, Mancastroppa, Glf, Corsini, E, Tedeschi, A, Gaglianò, Ms, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Di Bartolo, P, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, Me, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, Ap, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, Pc, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, Ml, Coletti, Mf, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, Ce, Agrusta, M., Vaccaro, Olga, Masulli, Maria, Nicolucci, Antonio, Bonora, Enzo, Del Prato, Stefano, Maggioni, Aldo P, Rivellese, Angela A, Squatrito, Sebastiano, Giorda, Carlo B, Sesti, Giorgio, Mocarelli, Paolo, Lucisano, Giuseppe, Sacco, Michele, Signorini, Stefano, Cappellini, Fabrizio, Perriello, Gabriele, Babini, Anna Carla, Lapolla, Annunziata, Gregori, Giovanna, Giordano, Carla, Corsi, Laura, Buzzetti, Raffaella, Clemente, Gennaro, Di Cianni, Graziano, Iannarelli, Rossella, Cordera, Renzo, La Macchia, Olga, Zamboni, Chiara, Scaranna, Cristiana, Boemi, Massimo, Iovine, Ciro, Lauro, Davide, Leotta, Sergio, Dall'Aglio, Elisabetta, Cannarsa, Emanuela, Tonutti, Laura, Pugliese, Giuseppe, Bossi, Antonio C, Anichini, Roberto, Dotta, Francesco, Di Benedetto, Antonino, Citro, Giuseppe, Antenucci, Daniela, Ricci, Lucia, Giorgino, Francesco, Santini, Costanza, Gnasso, Agostino, De Cosmo, Salvatore, Zavaroni, Donatella, Vedovato, Monica, Consoli, Agostino, Calabrese, Maria, Di Bartolo, Paolo, Fornengo, Paolo, Riccardi, Gabriele, Maggioni, Aldo Pietro, D'Angelo, Federica, Giansanti, Roberto, Tanase, Laura, Lanari, Luigi, Testa, Ivano, Pancani, Francesca, Ranchelli, Anna, Vagheggi, Paolo, Scatona, Alessia, Fontana, Lucia, Laviola, Luigi, Tarantino, Lucia, Ippolito, Claudia, Gigantelli, Vittoria, Manicone, Mariangela, Conte, Eleonora, Trevisan, Roberto, Rota, Rossella, Corsi, Anna, Dodesini, Alessandro R., Reggiani, Giulio Marchesini, Montesi, Luca, Mazzella, Natalia, Forlani, Gabriele, Caselli, Chiara, Di Luzio, Raffaella, Mazzotti, Arianna, Aiello, Antimo, Barrea, Angelina, Musto, Antonio, D'Amico, Fiorentina, Sinagra, Tiziana, Longhitano, Sara, Trowpea, Vanessa, Sparti, Maria, Italia, Salvatore, Lisi, Enrico, Grasso, Giuseppe, Pezzino, Vincenzo, Insalaco, Federica, Carallo, Claudio, Scicchitano, Caterina, De Franceschi, Maria Serena, Calbucci, Giovanni, Ripani, Raffaella, Cuneo, Giacomo, Corsi, Simona, Giorda, Carlo B., Romeo, Francesco, Lesina, Annalisa, Comoglio, Marco, Bonetto, Caterina, Robusto, Anna, Nada, Elisa, Asprino, Vincenzo, Cetraro, Rosa, Impieri, Michelina, Lucchese, Giuseppe, Donnarumma, Giovanna, Tizio, Biagio, Lenza, Lazzaro, Paraggio, Pia, Tomasi, Franco, Dozio, Nicoletta, Scalambra, Egle, Mannucci, Edoardo, Lamanna, Caterina, Cignarelli, Mauro, Macchia, Olga La, Fariello, Stefania, Sorrentino, Maria Rosaria, Franzetti, Ivano, Radin, Raffaella, Annunziata, Francesca, Bonabello, Laura Affinito, Durante, Arianna, Dolcino, Mara, Gallo, Fiorenza, Mazzucchelli, Chiara, Aleo, Anna, Melga, Pierluigi, Briatore, Lucia, Maggi, Davide, Storace, Daniela, Cecoli, Francesca, D'Ugo, Ercole, Pupillo, Mario, Baldassarre, Maria Pompea Antonia, Salvati, Filippo, Minnucci, Anita, De Luca, Angelo, Zugaro, Antonella, Santarelli, Livia, Bosco, Angela, Petrella, Vittorio, La Verghetta, Grazia Giovanna, De Gregorio, Antonella, D'Andrea, Settimio, Giuliani, Anna Elisa, Polidoro, W. Lorella, Sperandio, Alessandra, Sciarretta, Filomena, Pezzella, Alfonso, Carlone, Angela, Potenziani, Stella, Venditti, Chiara, Foffi, Chiara, Carbone, Salvatore, Cipolloni, Laura, Moretti, Chiara, Leto, Gaetano, Serra, Rosalia, Petrachi, Francesca, Romano, Isabella, Lacaria, Emilia, Russo, Laura, Goretti, Chiara, Sannino, Claudia, Dolci, Maria, Bruselli, Laura, Mori, Mary L., Baccetti, Fabio, Del Freo, Maria, Cucinotta, Domenico, Giunta, Loretta, Ruffo, Maria Concetta, Cannizzaro, Desiree, Pintaudi, Basilio, Perrone, Giovanni, Pata, Pietro, Ragonese, Francesco, Lettina, Gabriele, Mancuso, Teresa, Coppolino, Aldo, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Lucotti, Pietro, Setola, Manuela, Crippa, Giulia Valentina, Loi, Cinzia, Oldani, Matteo, Bottalico, Maria Luisa, Pellegata, Beatrice, Bonomo, Matteo, Menicatti, Laura Silvia Maria, Resi, Veronica, Bertuzzi, Federico, Disoteo, Eugenia Olga, Pizzi, Gianluigi, Rivellese, Angela Albarosa, Annuzzi, Giovanni, Capaldo, Brunella, Nappo, Rossella, Auciello, Stefania Michela, Turco, Anna Amelia, Costagliola, Lucia, Corte, Giuseppina Della, Vallefuoco, Pasquale, Nappi, Francesca, Vitale, Marilena, Cocozza, Sara, Ciano, Ornella, Massimino, Elena, Garofalo, Nadia, Avogaro, Angelo, Guarneri, Gabriella, Fedele, Domenico, Sartor, Giovanni, Chilelli, Nino Cristiano, Burlina, Silvia, Bonsembiante, Barbara, Galluzzo, Aldo, Torregrossa, Vittoria, Mancastroppa, Giovanni, Arsenio, Leone, Cioni, Federico, Caronna, Silvana, Papi, Matteo, Babini, Massimiliano, Santeusanio, Fausto, Calagreti, Gioia, Timi, Alessia, Tantucci, Alice, Marino, Cecilia, Ginestra, Federica, Di Biagio, Rosamaria, Taraborelli, Merilda, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Politi, Konstantina Savina, Penno, Giuseppe, Livraga, Stefania, Calzoni, Fabio, Mancastroppa, Giovanni Luigi Francesco, Corsini, Elisa, Tedeschi, Anna, Gaglianã², Maria Sole, Ippolito, Giulio, Salutini, Elisabetta, Cervellino, Francesco, Natale, Maria, Salvatore, Vita, Zampino, Armando, Sinisi, Rosa, Arcangeli, Adolfo, Zogheri, Alessia, Guizzotti, Sandra, Longo, Rossella, Pellicano, Francesca, Scolozzi, Patrizia, Termine, Simona, Luberto, Alessandra, Ballardini, Giorgio, Trojani, Cristina, Mazzuca, Paolo, Bruglia, Matteo, Ciamei, Monica, Genghini, Silvia, Zannoni, Chiara, Vitale, Martina, Rangel, Graziela, Salvi, Laura, Zappaterreno, Alessandra, Cordone, Samantha, Simonelli, Paola, Meggiorini, Marilla, Frasheri, Aurora, Di Pippo, Clelia, Maglio, Cristina, Mazzitelli, Giulia, Rinaldi, Maria Elena, Galli, Angelica, Romano, Maria, D'Angelo, Paola, Suraci, Concetta, Bacci, Simonetta, Palena, Antonio Pio, Genovese, Stefano, Mancino, Monica, Rondinelli, Maurizio, Capone, Filippo, Calabretto, Elisabetta, Bulgheroni, Monica, Bucciarelli, Loredana, Ceccarelli, Elena, Fondelli, Cecilia, Santacroce, Clorinda, Guarino, Elisa, Nigi, Laura, Lalli, Carlo, Di Vizia, Giovanni, Scarponi, Maura, Montani, Valeria, Di Bernardino, Paolo, Romagni, Paola, Dolcetti, Katia, Forte, Elisa, Tamburo, Lucilla, Perin, Paolo Cavallo, Prinzis, Tania, Gruden, Gabriella, Bruno, Graziella, Zucco, Chiara, Perotta, Massimo, Marena, Saverio, Monsignore, Simona, Panero, Francesco, Ponzi, Fulvia, Bossi, Antonio Carlo, Carpinteri, Rita, Casagrande, Maria Linda, Coletti, Maria Francesca, Balini, Annalisa, Filopanti, Marcello, Madaschi, Sara, Pulcina, Anna, Grimaldi, Franco, Venturini, Giorgio, Agus, Sandra, Pagnutti, Stefania, Guidotti, Francesca, Cavarape, Alessandro, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Fainelli, Giulia, Tomasetto, Elena, Zoppini, Giacomo, Galletti, Anna, Perrone, Dominica, Capra, Claudio, Bianchini, Francesca, Ceseri, Martina, Di Nardo, Barbara, Sasso, Elisa, Bartolomei, Barbara, Suliman, Irina, Fabbri, Gianna, Romano, Geremia, Maturo, Nicola, Nunziata, Giuseppe, Capobianco, Giuseppe, De Simone, Giuseppina, Villa, Valeria, Rota, Giuseppe, Pentangelo, Carmine, Carbonara, Ornella, Caiazzo, Gennaro, Cutolo, Michele, Sorrentino, Tommasina, Mastrilli, Valeria, Amelia, Umberto, Masi, Stefano, Corigliano, Gerardo, Gaeta, Iole, Armentano, Vincenzo, Calatola, Pasqualino, Capuano, Gelsomina, Angiulli, Bruno, Auletta, Pasquale, Petraroli, Ettore, Iodice, Cinzia E., Agrusta, Mariano, Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, di Bartolo, Paolo, Polidoro, w Lorella, Sartore, Giovanni, and Gaglianò, Maria Sole

Subjects
Male, Diabetes and Metabolism, ipoglycemic drugs, cardiovascualr event, Settore MED/09 - Medicina Interna, endocrine system diseases, IMPACT, pioglitazone versus sulfonylureas, Endocrinology, Diabetes and Metabolism, GLIMEPIRIDE, Diabetes, cardiovascular events, metformin, pioglitazone, sulphonylureas, Type 2 diabetes, 030204 cardiovascular system & hematology, Internal Medicine, Endocrinology, law.invention, Settore MED/13 - Endocrinologia, Glibenclamide, 0302 clinical medicine, Randomized controlled trial, law, GLYCEMIC CONTROL, Gliclazide, Internal medicine, diabetes and metabolism, RISK, education.field_of_study, diabetes, Incidence, endocrinology, diabetes and metabolism, endocrinology, Middle Aged, INSULIN, Metformin, Treatment Outcome, Editorial, sulphonylureas, Cardiovascular Diseases, Combination, Drug Therapy, Combination, Female, Type 2, medicine.drug, medicine.medical_specialty, Population, 030209 endocrinology & metabolism, Aged, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Pioglitazone, Sulfonylurea Compounds, Thiazolidinediones, Cardiovascular events, 03 medical and health sciences, GLUCOSE-LOWERING DRUGS, Drug Therapy, Diabetes Mellitus, medicine, sulfonylureas, education, TOSCA.IT, business.industry, MORTALITY, nutritional and metabolic diseases, Insulin resistance, medicine.disease, Surgery, Glimepiride, business, FOLLOW-UP
Abstract

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50–75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2–3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15–45 mg) or a sulfonylurea (5–15 mg glibenclamide, 2–6 mg glimepiride, or 30–120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-years) who were given sulfonylureas (hazard ratio 0·96, 95% CI 0·74–1·26, p=0·79). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p

Published
2017
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8. Clinical significance of nonalbuminuric renal impairment in type 2 diabetes

Author

Penno, G., Solini, A., Bonora, E., Fondelli, C., Orsi, E., Zerbini, G., Trevisan, R., Vedovato, M., Gruden, G., Cavalot, F., Cignarelli, M., Laviola, L., Morano, S., Nicolucci, A., Pugliese, G., RIACE Study Group, Pugliese, G, Penno, G, Solini, A, Bonora, E, Orsi, E, Trevisan, R, Laviola, L, Nicolucci, A, De Cosmo, S, Gruden, G, Morano, S, Pugliese, F, Zerbini, G, Simonelli, P, Negro, A, Salvi, L, Bazuro, A, Frasheri, A, Cavallo Perin, P, Lorenzati, B, Trovati, M, Anfossi, G, Cavalot, F, Chirio, M, Martina, V, Dolci, A, Pontiroli, A, Laneri, M, Arosio, M, Rossi, A, Montefusco, L, Corsi, A, Zoppini, G, Avogaro, A, Vedovato, M, Pagnin, E, Pucci, L, Lucchesi, D, Storti, E, Dotta, Francesco, Fondelli, C, Nigi, L, Gatti, A, Mandosi, E, Fallarino, M, Buzzetti, R, Leto, G, Cignarelli, M, Lamacchia, O, Pinnelli, S, Giorgino, F, Perrini, S, Sesti, G, Andreozzi, F, Baroni, Mg, Frau, G., Penno, G, Solini, A, Bonora, E, Fondelli, C, Orsi, E, Zerbini, G, Trevisan, R, Vedovato, M, Gruden, G, Cavalot, F, Cignarelli, M, Laviola, L, Morano, S, Nicolucci, A, and Pugliese, G

Subjects
Male, albuminuria, cardiovascular disease, gfr, type 2 diabetes, medicine.medical_specialty, Physiology, Cardiovascular risk factors, MEDLINE, Renal function, Type 2 diabetes, GFR, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Clinical significance, albuminuria, cardiovascular disease, GFR, type 2 diabetes, type 2 diabete, business.industry, medicine.disease, chronic kidney disease, Diabetes Mellitus, Type 2, Albuminuria, Female, Kidney Diseases, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Glomerular Filtration Rate
Abstract

Objective: In type 2 diabetes, prevalence of nonalbuminuric renal impairment is increasing worldwide, though its clinical significance remains unclear. This large-cohort study aimed at evaluating the association of this phenotype with cardiovascular risk factors and other complications. Methods: Type 2 diabetic patients from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study (n=15773), visiting consecutively 19 hospital-based Diabetes Clinics in years 2007-2008, were examined. Serum creatinine was assessed by the Jaffe method; albuminuria was measured by immunonephelometry or immunoturbidimetry. Results: Of patients with renal impairment, as identified by an estimated glomerular filtration rate (eGFR) less than 60ml/min per 1.73m, 56.6% were normoalbuminuric, 30.8% were microalbuminuric, and 12.6% were macroalbuminuric. Percentages were similar when GFR was estimated using the more accurate Chronic Kidney Disease Epidemiology Collaboration equation instead of the simplified Modification of Diet in Renal Disease formula, and were independent of age, thus indicating that the increasing prevalence of this phenotype does not reflects misclassification of elderly patients. Nonalbuminuric renal impairment was not associated with HbA1c and correlated less strongly with retinopathy and hypertension than albuminuria, either alone or associated with reduced eGFR. It was associated with a higher prevalence of cardiovascular disease (CVD) than albuminuria alone, but lower than albuminuric renal impairment. Female sex correlated with nonalbuminuric renal impairment and male sex with the albuminuric forms. Conclusion:S: These data show that type 2 diabetic patients with nonalbuminuric renal impairment exhibit distinct clinical features, suggesting predominance of macroangiopathy as underlying renal pathology, and that this phenotype is associated with significant CVD burden.

Published
2011
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9. Gender differences in cardiovascular disease risk factors, treatments and complications in patients with type 2 diabetes: the RIACE Italian multicentre study

Author

Penno, G, Solini, A, Bonora, E, Fondelli, C, Orsi, E, Zerbini, G, Trevisan, R, Vedovato, M, Gruden, G, Laviola, L, Nicolucci, A, Pugliese, G, Renal Insufficiency And Cardiovascular Events study group, De Cosmo, S, Morano, S, Pugliese, F, Simonelli, P, Salvi, L, Mazzitelli, G, Bazuro, A, Frasheri, A, Cavallo Perin, P, Lorenzati, B, Trovati, M, Anfossi, G, Cavalot, F, Chirio, M, Martina, V, Montefusco, L, Zimbalatti, D, Pontiroli, A, Veronelli, A, Zecchini, B, Arosio, M, Dolci, A, Corsi, A, Zoppini, G, Avogaro, A, Pagnin, E, Pisana, U, Pucci, L, Lucchesi, D, Russo, E, Garofolo, M, Dotta, Francesco, Nigi, L, Gatti, A, Buzzetti, R, Cignarelli, M, Lamacchia, O, Pinnelli, S, Giorgino, F, Perrini, S, Sesti, G, Andreozzi, F, Baroni, Mg, Frau, G, Nicolucci, A., Penno, G, Solini, A, Bonora, E, Fondelli, C, Orsi, E, Zerbini, G, Trevisan, R, Vedovato, M, Gruden, G, Laviola, L, Nicolucci, A, and Pugliese, G

Subjects
Male, medicine.medical_specialty, Waist, complications, cardiovascular disease risk factors, Hypercholesterolemia, Type 2 diabetes, treatment disparities, Severity of Illness Index, Type 2 diabete, Body Mass Index, gender, type 2 diabetes, Sex Factors, Risk Factors, Diabetes mellitus, Internal medicine, Internal Medicine, medicine, Humans, Aged, Treatment disparitie, business.industry, Confounding, Middle Aged, medicine.disease, Prognosis, Obesity, Survival Analysis, Surgery, Blood pressure, Cross-Sectional Studies, Treatment Outcome, Diabetes Mellitus, Type 2, Italy, Cardiovascular Diseases, Hyperglycemia, Cohort, Hypertension, Female, Cardiovascular disease risk factor, business, Complication, Body mass index
Abstract

Objectives Poorer control of risk factors for cardiovascular disease (CVD) has been reported in diabetic women, as compared with diabetic men. It has been proposed that this finding is due to gender disparities in treatment intensity. We investigated this hypothesis in a large contemporary cohort of subjects with type 2 diabetes. Design Observational, cross-sectional study. Subjects and setting Consecutive patients with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events (RIACE) Italian multicentre study (n = 15 773), attending 19 hospital-based diabetes clinics in 2007–2008. Main outcome measures Traditional CVD risk factors, macro- and microvascular complications and current glucose-, lipid- and blood pressure (BP)-lowering treatments were assessed. Results Although CVD was more prevalent in men, women showed a less favourable CVD risk profile and worse performance in achieving treatment targets for haemoglobin A1c, LDL, HDL and non-HDL cholesterol, systolic blood pressure (BP) and in particular obesity [body mass index (BMI) and waist circumference], but not for triglycerides and diastolic BP. However, women were more frequently receiving pharmacological treatment for hypertension and to a lesser extent hyperglycaemia and dyslipidaemia than men, and female gender remained an independent predictor of unmet therapeutic targets after adjustment for confounders such as treatments, BMI, duration of diabetes and, except for the systolic BP goal, age. Conclusions In women with type 2 diabetes from the RIACE cohort, a more adverse CVD risk profile and a higher likelihood of failing treatment targets, compared with men, were not associated with treatment differences. This suggests that factors other than gender disparities in treatment intensity are responsible.

Published
2013

10. Relationship of exercise volume to improvements of quality of life with supervised exercise training in patients with type 2 diabetes in a randomised controlled trial: the Italian Diabetes and Exercise Study (IDES)

Author

Nicolucci, A, Balducci, S, Cardelli, P, Cavallo, S, Fallucca, S, Bazuro, A, Simonelli, P, Iacobini, C, Zanuso, S, Pugliese, G, DI MAURO, Maurizio, and Italian Diabetes Exercise Study Investigators

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, MEDLINE, Type 2 diabetes, Fitness Centers, Metabolic equivalent, law.invention, Body Mass Index, Cohort Studies, Physical medicine and rehabilitation, Randomized controlled trial, Quality of life, Patient Education as Topic, law, Diabetes mellitus, Surveys and Questionnaires, Internal Medicine, medicine, Humans, exercise, quality of life, physical activity, type 2 diabetes, Exercise, Life Style, Type 2 Diabetes, Glycated Hemoglobin, Psychiatric Status Rating Scales, business.industry, Resistance Training, Middle Aged, medicine.disease, Diabetes Mellitus, Type 2, Italy, Physical therapy, Quality of Life, Female, Sedentary Behavior, business, Body mass index, Cohort study
Abstract

A positive impact of exercise intervention programmes on quality of life (QoL) may be important for long-term patient compliance to exercise recommendations. We have previously shown that QoL improves significantly with supervised exercise, whereas it worsens with counselling alone, in patients with type 2 diabetes from the Italian Diabetes and Exercise Study (IDES). Here, we report data on the relationship between changes in QoL and volume of physical activity/exercise in these individuals. This multicentre parallel randomised controlled, open-label, trial enrolled sedentary patients with type 2 diabetes (n = 606 of 691 eligible) in 22 outpatient diabetes clinics. Patients were randomised by centre, age and diabetes treatment using a permuted-block design to twice-a-week supervised aerobic and resistance training plus exercise counselling (exercise group) versus counselling alone (control group) for 12 months. Health-related QoL was assessed by the 36-Item Short Form (SF-36) Health Survey. In the exercise group (n = 268 of 303 randomised), there was a trend for increasing QoL with increasing exercise volume, with significant improvement of the physical component summary (PCS) measure only above 17.5 metabolic equivalents h−1 week−1 and a clear volume-relationship for the mental component summary (MCS) measure. A relationship with volume of physical activity also was observed in the control group (n = 260 of 303 randomised), despite overall deterioration of all scores. Independent correlates of improvements in both PCS and MCS were exercise volume, study arm and, inversely, baseline score. This large trial shows a relationship between changes in physical and mental health-related QoL measures and volume of physical activity/exercise, with supervised exercise training also providing volume-independent benefits. ISRCTN-04252749 The study was funded by Lifescan SrL, Novo Nordisk Ltd, Bristol Myers Squibb Italy, Technogym SpA and Cosmed SrL.

Published
2012

11. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial

Author

King TE Jr, Albera, C, Bradford, Wz, Costabel, U, Hormel, P, Lancaster, L, Noble, Pw, Sahn, Sa, Szwarcberg, J, Thomeer, M, Valeyre, D, du Bois RM, INSPIRE Study Group, Agostini, Carlo, Allen, J, Anzueto, A, Behr, J, Bonnet, R, Buhl, R, Burge, S, Chan, A, Chan, C, Chanez, P, Chapman, J, Cordier, J, Covelli, H, Crimi, N, de Andrade, J, Delaval, P, Dromer, C, Egan, J, Enelow, R, Ettinger, N, Flaherty, K, Floreani, A, Frankel, S, Frost, A, Gibson, K, Glassberg, M, Gottfried, M, Harari, S, Helmersen, D, Hollingsworth, H, Horton, M, Jennings, J, Kallay, M, Lasky, J, Lee, A, Leonard, C, Lorch, D, Lynch, J, Mageto, Y, Mette, S, Millar, A, Morell Brotad, F, Müller Quernheim, J, Nathan, S, Noth, I, Padilla, M, Poletti, V, Raghu, G, Richeldi, L, Robbins, M, Rolf, J, Roman, J, Rosen, G, Rottoli, P, Saltini, C, Schaberg, T, Schaumberg, T, Scholand, M, Schönfeld, N, Sharma, S, Simonelli, P, Steele, M, Sussman, R, Tino, G, Vogelmeier, C, Wallaert, B, Wells, A, Wencel, M, Wesselius, L, Whelan, T, Wilcox, P, Wolters, P, Xaubet, A, and Zisman, D.

Subjects
Male, medicine.medical_specialty, Settore MED/10 - Malattie dell'Apparato Respiratorio, Injections, Subcutaneous, Vital Capacity, Placebo-controlled study, Kaplan-Meier Estimate, Placebo, Severity of Illness Index, Drug Administration Schedule, Pulmonary function testing, Injections, Idiopathic pulmonary fibrosis, Interferon-gamma, Double-Blind Method, Internal medicine, Pulmonary fibrosis, medicine, Humans, Aged, Analysis of Variance, Disease Progression, Europe, Exercise Test, Female, Idiopathic Pulmonary Fibrosis, North America, Proportional Hazards Models, Pulmonary Diffusing Capacity, Recombinant Proteins, Survival Rate, Treatment Failure, Medicine (all), Survival rate, business.industry, Subcutaneous, Hazard ratio, General Medicine, Interim analysis, medicine.disease, Surgery, business
Abstract

Summary Background Idiopathic pulmonary fibrosis is a fatal disease for which no effective treatment exists. We assessed whether treatment with interferon gamma-1b improved survival compared with placebo in patients with idiopathic pulmonary fibrosis and mild-to-moderate impairment of pulmonary function. Methods 826 patients with idiopathic pulmonary fibrosis were enrolled from 81 centres in seven European countries, the USA, and Canada. Patients were randomly assigned (double-blind) in a 2:1 ratio to receive 200 μg interferon gamma-1b (n=551) or equivalent placebo (n=275) subcutaneously, three times per week. Eligible patients were aged 40–79 years, had been diagnosed in the past 48 months, had a forced vital capacity of 55–90% of the predicted value, and a haemoglobin-corrected carbon monoxide diffusing capacity of 35–90% of the predicted value. The primary endpoint was overall survival time from randomisation measured at the second interim analysis, when the proportion of deaths had reached 75% of those expected by the study conclusion. This study is registered with ClinicalTrials.gov, number NCT00075998. Findings At the second interim analysis, the hazard ratio for mortality in patients on interferon gamma-1b showed absence of minimum benefit compared with placebo (1·15, 95% CI 0·77–1·71, p=0·497), and indicated that the study should be stopped. After a median duration of 64 weeks (IQR 41–84) on treatment, 80 (15%) patients on interferon gamma-1b and 35 (13%) on placebo had died. Almost all patients reported at least one adverse event, and more patients on interferon gamma-1b group had constitutional signs and symptoms (influenza-like illness, fatigue, fever, and chills) than did those on placebo. Occurrence of serious adverse events (eg, pneumonia, respiratory failure) was similar for both treatment groups. Treatment adherence was good and few patients discontinued treatment prematurely in either group. Interpretation We cannot recommend treatment with interferon gamma-1b since the drug did not improve survival for patients with idiopathic pulmonary fibrosis, which refutes previous findings from subgroup analyses of survival in studies of patients with mild-to-moderate physiological impairment of pulmonary function. Funding InterMune.

Published
2009

12. [Treatment of ischemic heart disease in the elderly. Comparison of diltiazem, verapamil and gallopamil]

Author

Simonelli P, Papa A, Macciocchi B, Auriemma F, Vetrano A, Scaletta Romeo di Santillo M, and Antonio Ceriello

Subjects
Male, Age Factors, Myocardial Ischemia, Coronary Disease, Middle Aged, Coronary Angiography, Angina Pectoris, Diltiazem, Verapamil, Exercise Test, Drug Evaluation, Humans, Female, Gallopamil, Aged
Abstract

The medical therapy of myocardial ischemia in elderly patients has not been well evaluated. We studied the age-related changes in 127 patients with proved coronary artery disease and stable effort angina the efficacy and the safety of diltiazem 120 mg tid, verapamil 120 mg tid and gallopamil 50 mg tid a medium term parallel, double blind cross-over placebo controlled study. All patients have been clinically and ergometrically evaluated. In middle-age patients diltiazem, verapamil and gallopamil induced a significant increasing of exercise duration and time to onset ST segment depressionor = 1 mm. In the elderly patients both verapamil and diltiazem as increased the exercise duration and ischemic threshold, while the diltiazem did not increased the exercise duration even if the time of onset ST segment depressionor = 1 mm is increased. At peak exercise the ST segment depression have been reduced both in middle-age and elderly patients after active drugs. Weekly angina and DNT consumption have been significantly reduced after diltiazem, verapamil and gallopamil in middle-age and elderly patients. Side effects have not been relevant even if gallopamil as a lower frequency of them in comparison to diltiazem and verapamil. No patients stopped the treatment because major side effects. Our experience suggests that diltiazem, verapamil and gallopamil have a similar efficacy and rare well tolerated. The choice of one instead of another must be suggested on the basis of side effects developing.

Published
1993

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